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The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or sacral spine.

The provided text describes a 510(k) premarket notification for the Aurora Spine ZIP™ MIS Interspinous Fusion System. This document is a regulatory submission for a medical device and does not contain information about clinical performance testing or studies evaluating the device's adherence to specific acceptance criteria for AI/ML performance.

Specifically, the "Clinical Performance Testing Summary" section states: "A literature review of was performed to support the expanded indications." This implies that no new clinical study was conducted for this specific 510(k) submission to assess performance against acceptance criteria. The submission focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, and a literature review for an expanded indication (lumbar spinal stenosis).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this data is not present in the provided document.

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The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

This document is a 510(k) premarket notification for a medical device called the "ZIP™ MIS Interspinous Fusion System" by Aurora Spine, Incorporated. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device is a mechanical implant, not an AI/ML-driven device or an imaging device, and therefore the concepts of acceptance criteria regarding accuracy, precision, sensitivity, specificity, MRMC studies, or standalone algorithm performance are not applicable in the way they would be for AI-based diagnostic tools.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biological performance of the implant and its substantial equivalence to a predicate device.

Here's an attempt to answer the questions based on what is available and extrapolate where necessary, acknowledging the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a discrete table of acceptance criteria with corresponding performance metrics in a format typical for AI/ML device evaluations. Instead, the acceptance criterion is implicitly "substantial equivalence" to a predicate device in terms of safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial test set for software. The primary "test set" for this submission was the CAD models used for Finite Element Analysis (FEA) of the device's mechanical properties. The document does not specify the number of FEA models or simulations.
• Data Provenance: The FEA testing would be computational and likely performed by the manufacturer or a contract lab. Country of origin of data is not specified but would be related to the location of the FEA execution. This is a non-clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Ground Truth Experts: Not explicitly stated. For a mechanical device being evaluated via FEA, the "ground truth" for the FEA would be based on engineering principles, materials science data, and established biomechanical models. The expertise would lie with the engineers and scientists who designed the FEA models and interpreted the results. This doesn't involve medical experts in the way AI image analysis would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This concept is typically for resolving discrepancies in human expert interpretations of ground truth for diagnostic tests. For FEA, the results are computational and typically verified through engineering checks and comparisons to known benchmarks or predicate device performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This type of study is completely irrelevant for a mechanical interspinous fusion system. MRMC studies are for evaluating the diagnostic performance of AI algorithms, particularly in imaging.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This device is a surgical implant, not an algorithm. Its performance is physical and biological, not computational in a diagnostic sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the non-clinical testing, the "ground truth" for the FEA simulations would be based on:
  • Engineering principles and material properties: Known physical laws and validated material data.
  • Predicate device performance data: The performance of the previously cleared predicate device serves as the benchmark against which the modified device is compared to establish substantial equivalence.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, this 510(k) submission is for a modification to a mechanical surgical implant. The "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, primarily through non-clinical mechanical testing (Finite Element Analysis) rather than clinical studies or evaluations of AI performance.

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The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

The Aurora Spine ZIPTM MIS Interspinous Fusion System is a medical device that adds new sizes and configurations to the Aurora Spine ZIPTM MIS Interspinous Fusion System. This device is a posterior, non-pedicle supplemental fixation device. It is intended for use in the non-cervical spine (T1-S1). This device is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor.

Here's an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary is for a Special 510(k) submission, which typically means adding new sizes and configurations to an already cleared device (predicate device K133091). For such submissions, the primary acceptance criteria revolve around demonstrating that the modifications do not alter the fundamental safety and effectiveness of the device compared to the predicate. This is often achieved through comparative analysis and engineering testing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of clinical or image-based test sets. The study involved finite element analysis (FEA) and engineering rationales of the modified components. This means computational models were used, not patient data or physical test samples in the traditional sense of a "test set" for AI/software.
• Data Provenance: Not applicable. This is a mechanical/computational study, not a clinical data study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts & Qualifications: Not applicable. For FEA and engineering rationales, the "ground truth" is established by adherence to engineering principles, material science, and validated computational methods, often overseen by qualified engineers and biomechanics specialists. No human experts in the context of clinical review were used to establish ground truth for this type of study.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a mechanical/computational study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

• MRMC Study: No. This submission describes a mechanical engineering study, not an MRMC study related to AI or human reader performance. This device is a physical implant, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Study: Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone performance does not apply.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this engineering study is based on established mechanical engineering principles, material properties, and the validated performance of the predicate device. The FEA models are built upon these principles, and their results are compared against the expected performance derived from the predicate and relevant ASTM standards (ASTM F1717-13).

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI/machine learning study that would involve a "training set." The "training" in this context is the validation of the FEA models and engineering methodologies against known physical properties and standards.

9. How the Ground Truth for the Training Set was Established

• How Ground Truth for Training was Established: Not applicable. There isn't a "training set" in the sense of data labeled by experts. The "ground truth" for ensuring the accuracy of the computational methods (FEA) would be established through:
  • Validation of FEA models: Comparing FEA predictions to physical test results of components (either the predicate or test coupons) where experimental data is available.
  • Adherence to ASTM standards: Ensuring the simulation parameters and failure criteria align with recognized industry standards for spinal implant testing (e.g., ASTM F1717-13).
  • Engineering principles: The underlying equations and assumptions in finite element analysis are based on well-established principles of mechanics and material science.

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The Aurora Spine ZIPTM MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T)-SI). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The Aurora Spine ZIP™ MIS Interspinous Fusion System is manufactured from titanium alloy (Ti-6A1-4V ELI in accordance with ASTM F136 or ISO 5832-3).

This document describes a 510(k) submission for a medical device called the Aurora Spine ZIP™ MIS Interspinous Fusion System. It is a spinal implant, not an AI/ML device, and therefore the standard AI/ML device performance criteria, such as those related to accuracy, sensitivity, and specificity, are not applicable here.

Instead, the acceptance criteria for this type of device focus on substantial equivalence to existing legally marketed predicate devices, primarily demonstrated through biocompatibility, mechanical performance, and materials testing.

Here's an analysis based on the provided text, aligning with the spirit of your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document describes bench testing (mechanical testing), not a clinical study with patient samples. The "test set" here refers to the number of physical devices and test rigs used for mechanical evaluation. The exact number of devices tested for each mechanical test (static compression bending, static torsion, dynamic compression bending, and disassociation testing) is not specified in the provided 510(k) summary. However, such testing typically involves a statistically relevant number of samples to ensure reproducibility and reliability of results, as specified by the ASTM F1717 standard.
• Data Provenance: The data provenance for this bench testing is the manufacturer's internal testing facilities or a contracted testing laboratory. There's no mention of patient data or clinical trials, as this is a 510(k) submission primarily relying on substantial equivalence to predicates through non-clinical data. The data is prospective in the sense that the tests were conducted specifically for this submission to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable to this type of medical device submission. Ground truth, in the context of AI/ML or diagnostic devices, refers to a definitive diagnosis or outcome confirmed by human experts or other gold standards. For a spinal implant, "ground truth" is established by adherence to engineering standards (like ASTM F1717) and regulatory requirements, not by expert consensus on clinical cases. The "experts" in this context would be:
  • Engineers and material scientists conducting and interpreting the mechanical tests based on established standards.
  • FDA reviewers with expertise in orthopedic devices, biomechanics, and regulatory science, who evaluate the submitted data against compliance criteria. Their qualifications are not specified in the document but are inherent to their roles at the FDA.

4. Adjudication Method for the Test Set

• This question is not applicable to this type of medical device. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies or expert review panels to resolve discrepancies in diagnoses or interpretations, typically for diagnostic or imaging devices. For mechanical performance testing, the "adjudication" is met by demonstrating that the test results satisfy the quantitative criteria defined by the ASTM F1717 standard. If there were discrepancies in test results, they would be handled through repeat testing, error analysis, or re-design, rather than an expert adjudication process as understood in clinical evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This question is not applicable. An MRMC study is relevant for diagnostic imaging AI/ML devices where the performance of human readers (e.g., radiologists) is compared with and without AI assistance. The Aurora Spine ZIP™ MIS Interspinous Fusion System is a surgical implant for spinal fusion and does not involve "human readers" or "AI assistance" in its direct function or evaluation for this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is a concept that does not apply here.

7. The Type of Ground Truth Used

• The "ground truth" for this device, in the context of its 510(k) clearance, is demonstrated adherence to recognized consensus standards for mechanical performance (ASTM F1717) and material properties.
  • It is not expert consensus on clinical cases, pathology, or outcomes data, as these are typically part of a higher-level regulatory pathway (PMA) or post-market surveillance for novel devices. For a 510(k), the "ground truth" for showing substantial equivalence rests on demonstrating that the device meets established engineering and material specifications that are known to be safe and effective for similar predicate devices.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of this device. Training sets are used to develop and refine AI/ML algorithms. This device is a manufactured physical good, not a software algorithm.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reasons as #8.

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